Biosimilars and Future Biotherapeutics

Collaborative Models in Biosimilar Development

The development of biosimilars is a complex, resource-intensive process that requires advanced scientific capabilities, regulatory expertise, and significant financial investment. To overcome these challenges and accelerate product development while managing costs and risks, stakeholders across the biopharmaceutical industry are increasingly turning to collaborative models. These partnerships—ranging from public-private alliances and academic-industry collaborations to joint ventures and contract development and manufacturing organization (CDMO) engagements—have become a cornerstone of modern biosimilar strategy. At the heart of these collaborative approaches is the recognition that no single entity can address the technical, regulatory, and market-access complexities of biosimilars alone, particularly in a global environment characterized by diverse regulatory requirements and competitive pressures. Public-private partnerships (PPPs) are one of the most impactful models in biosimilar development, especially in low- and middle-income countries where capacity building and affordable access are key priorities. Government agencies, non-profits, and international organizations such as the World Health Organization (WHO), the Bill & Melinda Gates Foundation, and the Coalition for Epidemic Preparedness Innovations (CEPI) often team up with local manufacturers or multinational pharmaceutical companies to facilitate technology transfer, scale-up manufacturing, and streamline regulatory approval for biosimilars.